Women’s healthcare firm Organon has signed an agreement with Daré Bioscience for latter's Xaciato (clindamycin phosphate vaginal gel, 2%).
Under the deal, Organon will obtain global rights to FDA-approved Xaciato, which is intended to treat bacterial vaginosis (BV) in females aged 12 years and above.
The vaginal gel has received Fast Track and Qualified Infectious Disease Product (QIDP) designations from the US FDA for the treatment of bacterial vaginosis.
BV is said to be the most common cause of vaginitis and nearly 21 million US women are estimated to be affected.
Under the terms of the deal, Organon will make an upfront payment of $10m to Daré Bioscience, which is also eligible to receive up to $182.5m of potential milestone payments along with the tiered double-digit royalties based on net sales of the product.
Organon CEO Kevin Ali said: “Our agreement with Daré aligns well with our long-term growth strategy focused on delivering new options for women where therapeutic gaps exist.
“Organon will bring its commercial expertise to this collaboration so that we can deliver this option to women, specifically in a condition like bacterial vaginosis where more treatment choices are needed.”
Subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, the transaction is expected to be concluded in the second quarter of this year.
The Xaciato vaginal gel is anticipated to be commercially available in the US in the fourth quarter of this year.
Daré Bioscience president and CEO Sabrina Martucci Johnson said: “Organon shares our commitment to advance critically needed innovations in women’s health.
“We are excited to be collaborating with one of the premier companies in women’s health as we believe that Organon’s commercial capabilities will ensure that XACIATO reaches the women most impacted by this condition.”